MAUDE Adverse Event Report: COVIDIEN SPIDER FX; DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC

Catalog Number SPD2-US-060-320

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician placed a spider fx in the proximal popliteal artery as part of a procedure to place a stent in a slightly calcified, plaque lesion.There were no issues in placing the spider.The stent was delivered over the spider with no issues.A non-medtronic support catheter was placed over the spider to retrieve it.The spider appeared to have pulled back without any issue however, when the final angiograph was taken, the spider basket was seen in the proximal popliteal.The spider was safely removed with the micro snare.The retrieved catheter was inspected and the filter had detached.A micro snare was used to retrieve the filter and the procedure finished.Patient was discharged.There was no patient injury reported.

Manufacturer Narrative

Product analysis: the spiderfx capture wire was returned.No ancillary devices, cine, images or procedure notes were returned for evaluation.Visual inspection of the capture wire revealed the filter was detached.The filter was not returned for evaluation.The dual ended catheter was not returned for evaluation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPIDER FX
• Type of Device: DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8644123
• MDR Text Key: 146217432
• Report Number: 2183870-2019-00312
• Device Sequence Number: 1
• Product Code: NFA
• UDI-Device Identifier: 00821684068366
• UDI-Public: 00821684068366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Catalogue Number: SPD2-US-060-320
• Device Lot Number: A730984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• Date Device Manufactured: 10/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention